Clinical research associate jobs in Bolingbrook, IL - 331 jobs

Seeking an organized, outgoing and driven individual. The individual will be trained to become a member of the team, working with all health care professionals and staff to deliver high quality patient care. The Clinical Coordinator will be responsible for a number of pre/post operative DME products, toxicology screening program and other ancillary services. Position Duties: Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Provide exceptional customer service to all patients, providers, and staff Identify eligible patients and prioritize schedule Educate and guide providers and their staff on available services and therapies Dispense any needed products or services as directed by the provider and their care team Ensure that all necessary documentation is obtained and submitted to appropriate departments Efficiently navigate Electronic Medical Record (EMR) software, clinic schedules Track and maintain inventory Travel locally between practice locations and/or to set up devices Preferred Knowledge, Skills, Abilities and Experience: Excellent skills in verbal and written communication Judgment, decision making, and time management skills Ability to organize multiple projects and assignments at once Competencies: Communication Proficiency Ethical Conduct Organizational Skills Time Management Attention to detail Required Education: High School Degree or Equivalent Preferred Education: A BA or BS degree MA/RN/LPN

Department: MED-Impact Institute Salary/Grade: RES/ Hiring: HIV Implementation Science Coordination Initiative Project Director (Clinical Research Associate), Institute for Sexual and Gender Minority Health and Wellbeing Program Description: Implementation science (IS) is a relatively new field with exciting opportunities for growth and innovation focused on methods to promote the adoption and integration of evidence-based practices, interventions, and policies into routine healthcare and public health settings. The HIV Implementation Science Coordination Initiative (ISCI) is the national coordinating and technical support center for Centers for AIDS Research/AIDS Research Centers research-practice partnerships funded as part of the Ending the HIV Epidemic plan. ISCI provides high-quality IS coordination, consultation and data management for NIH-funded Ending the HIV Epidemic (EHE) implementation research teams and creates opportunities to share generalizable knowledge to help end the HIV epidemic in the United States. ICI identifies and disseminates best practices in HIV implementation research, while providing training, and resources to support academic researchers and practice-based partners. Position Description: The Project Director will lead project and personnel management for ISCI, overseeing complex multi-investigator projects across multiple institutions and supervising several research staff. This role involves developing and managing project plans with defined timelines, deliverables, and resources, while identifying opportunities for growth, assessing potential impacts, and collaborating with cross-functional teams to implement innovative solutions. The ideal candidate is an experienced leader with expertise in project management of complex, multi-investigator projects across multiple institutions, experience supervising multiple staff, strong written and oral communication skills, effective time management capabilities, and ability to work independently. The average target hiring range for this position will be between $80,000 - $95,000 per year. Final offered salary will be determined by the applicant's education, experience, knowledge, skills and abilities, as well as internal equity and alignment with market data. Duties and Responsibilities: Project and Personnel Management * Develops and implements comprehensive project plans, including timelines and deliverables. * Assists in the development and execution of new initiatives, leads strategic planning efforts to ensure alignment with project goals and objectives. * Identifies opportunities for project growth, assesses potential impacts, and collaborates with cross-functional teams to implement innovative solutions. * Leads and coordinates multiple teams, ensuring effective communication and collaboration across the project. * Trains, directs, assigns duties to, and supervises research staff and/or fellows. * Allocates and manages project resources, including personnel, budget, and materials, to ensure optimal project performance. * Acts as the primary contact for stakeholders (sponsoring agencies and collaborators), providing regular updates on project progress and addressing any issues or concerns. * Maintains project documentation, including project plans, progress reports, and final reports. * Ensures that all project activities adhere to quality standards and regulatory requirements. * Evaluates project outcomes and processes to identify areas for improvement and implement best practices. Administration * Analyzes, evaluates and interprets data to determine relevance to research. * Prepares results and may lead and co-author scientific papers for presentation and publication and disseminate information via seminars, lectures, etc. * Creates data for use in grant submission and develops new proposals for research including obtaining financial support. * Ensures that all study documents associated with current local, state, and federal regulatory guidelines, requirements, laws and research protocols are completed in a timely manner. Finance * May create and/or manage research study budget which may include deciding on and approving expenditures of funds based on budget. * Monitors accounts. * Ensures appropriate allocation and compliance. Miscellaneous * Performs other duties as assigned. Position Details: This is a full-time position based on the Chicago campus of Northwestern University. Minimum Qualifications (Education, experience, and any other certifications or clearances) * Master's or doctoral degree in social/behavioral science (e.g., psychology, sociology, anthropology), public health, humanities, or related field * At least 5 years of experience with managing complex projects that involve multiple principal investigators, sites, institutions, and/or public health practice settings. * Experience in project management and supervising multiple staff is required. * Experience using project management software. * Experience using Microsoft Office 365 and basic computer programs (e.g., Teams, Sharepoint, OneNote, Word, Excel, PowerPoint, Adobe, Google, etc.) * Must complete NU's IRB CITI training before interacting with any participants and must re-certify every 3 years. Minimum Competencies (Skills, knowledge, and abilities) * Strong project coordination skills and the ability to prioritize tasks. * Demonstrated attention to detail and ability to adhere to instructions/procedures. * Good communication skills; demonstrated effective spoken and written communication. * Good time management skills; efficient and resourceful in problem-solving. * Demonstrated ability to take ownership of the work, possessing initiative, good follow-through; ability to work without supervision. Preferred Competencies (Skills, knowledge, and abilities) * Familiarity with implementation science concepts (e.g., models and frameworks, determinants, outcomes, strategies, study designs). * Familiarity with HIV prevention and care research To apply: Applicants should email application materials to ********************* with the subject line "ISCI Project Director." Applications should include a CV and cover letter explaining fit with this position; relevant work or educational experiences, including experiences with research topic areas, and the names of two references who will be contacted only for finalists. Consideration of applications will begin immediately and continue until the position is filled. Northwestern University is an Equal Opportunity Employer and does not discriminate on the basis of protected characteristics, including disability and veteran status. View Northwestern's non-discrimination statement. Job applicants who wish to request an accommodation in the application or hiring process should contact the Office of Civil Rights and Title IX Compliance. View additional information on the accommodations process.

Piper Companies is currently seeking a Clinical Research Associate (CRA) for an opportunity in Chicago, Illinois (IL). The Clinical Research Associate (CRA) will participate in ongoing Clinical Trials throughout the Country for a leading Clinical Research Organization. Responsibilities for the Clinical Research Associate: * Conduct site and study visits and perform all site monitoring activities across multiple study * Responsible for both remote and on-site monitoring and study activation * Participate in the development of study tools, protocols, and clinical trial documentation * Some travel required once travel bands are lifted Qualifications for the Clinical Research Associate: * 2-4 years performing on-site monitoring and hands on experience with EDC Systems * Experience with Oncology is highly advantageous * Organization to perform monitoring duties across multiple sites is a must Compensation for the Clinical Research Associate: * Salary Range: $100,000-$120,000 * Comprehensive Benefits: Medical, Dental, Vision, 401K, PTO, Sick Leave as required by law, and Holidays #LI-SR1

Responsible for providing Clinical Research support for all clinical trials. Under the direction of supervisor or designee, this position will serve as support for the clinical study team. Essential Duties And Responsibilities Participate and assist in design and preparation of protocols and case report forms. Generate clinical SOPs, policies, charters, and plans according to US and international guidelines. Participate in the evaluation of potential clinical sites according to established criteria of acceptability. Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions. Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials. Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions. Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow -up actions for assigned study sites. Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission. Assist with the maintenance of clinical archive and electronic files. Other tasks as assigned. Requirements To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. BA, BS, RN, BSN or equivalent Basic knowledge and adherence to GCPs 1 -2 years of clinical research experience or equivalent experience or training Strong attention to detail Ability to multi -task Unquestionable integrity and highest ethical standards Excellent written and verbal communication skills Self -motivated, assertive, and driven BenefitsDental, Medical, Vision, PTO and 401K

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners' most high-profile drug and device programs. Position Overview This position is responsible for executing, managing and conducting projects associated with the company clinical study plans. The Contract Clinical Research Associate (CCRA) is responsible for site management deliverables on assigned protocols and may support other CRAs on the team. Essential Duties Include, but are not limited to, the following: Establish and maintain primary Sponsor communication with clinical sites for in-house and outsourced studies. Conduct oversight visits for outsourced studies to promote study engagement, enrollment and foster sponsor/site relationships. Serve as a point of contact for investigators and site staff. Maintain regular contact with study sites to ensure GCP/ICH/Protocol compliance, assessment of accrual rates. Facilitate communication between the project team and site personnel to ensure that they are appropriately trained, remain current with project requirements, and have a thorough understanding of study milestones and deliverables. Conduct thorough site qualifications visits. Ensure all required information concerning site/staff qualifications is clearly documented and communicated to project teams. Conduct efficient and comprehensive site initiation visits. Ensure all assigned site staff are trained appropriately, have access to the required electronic systems, and are informed of data collection, GCP, protocol and reporting requirements. Ensure monitoring visits are scheduled and performed per the Monitoring Plan and according to the performance of the clinical site and the project team needs. Maintain a flexible monitoring schedule (as appropriate) and assist in co-monitoring or monitoring support of clinical sites/studies. Conduct study specific training for new study coordinators (protocol, ICH/GCP and regulatory guidelines and study specific requirements). Ensure all clinical site staff actively participating in the study are appropriately trained. Identify if any untrained staff are participating in Clinical trial activities, document and communicate the issues and suggested resolutions to the Clinical site and project team. Conduct device/product accountability responsibilities at clinical sites; Identify, clearly communicate and document issues to the clinical site and project team. Assist clinical site in resolving issues, if appropriate. Participate in all aspects of site close-out activities (i.e., evaluation of site readiness for final IMV, preparation for Database lock, etc.). Communicate status of Site management activities on a routine basis to the Clinical Project team and management. Actively participate as an extended team member of the clinical study team including participating in study-specific meetings, teleconferences and investigator meetings, clear and timely communication with cross functional partners and CRA team members. Implement and execute the clinical study Monitoring Plan to ensure compliance with the plan and all assigned tasks throughout the study. Ensure clear and efficient written communication to clinical sites (confirmation letter, site visit report, follow up letter, requests for remediation or action) and project team members. Communicate project specific information to/from trial sites through teleconferences, newsletters, etc. Work with clinical project manager to assure investigator payments are appropriate and paid on a timely basis. Document monitoring activities in monitoring visit reports and follow-up letters. Communicate serious issues to appropriate parties, in a timely manner. Ensure operational and regulatory integrity of assigned studies and participate in FDA or other regulatory authority inspections, as needed. Participate in Investigator Meetings, and other study trainings and meetings as required. Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork. Support and comply with the company's Quality Management System policies and procedures. Maintain regular and reliable attendance. Ability to act with an inclusion mindset and model these behaviors for the organization. Ability to work designated schedule. Ability to work nights and/or weekends, as needed. Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day. Ability to work on a computer and phone simultaneously. Ability to use a telephone through a headset. Ability to travel 50% of working time away from work location may include overnight/weekend travel. Minimum Qualifications Bachelor's Degree in field as outlined in essential duties or Associate degree with a minimum of 6 years of monitoring experience or equivalent experience. Highschool Diploma with a minimum 8 years of monitoring experience or equivalent experience. 4+ years clinical research monitoring experience or equivalent experience. No other results from the Motor Vehicle Report (MVR) check that exposes Exact Sciences to what Exact Sciences deems to be an unacceptable level of liability. Proficiency in data management, including progressive experience in data entry, validation, and cleaning. Familiarity with Electronic Data Capture (EDC) systems. Effective communication skills and ability to collaborate with investigators, site staff, and team members. Demonstrated ability to work well within a team and convey information effectively. Understanding of regulatory compliance to ensure adherence to applicable regulations and requirements. Knowledge and experience in informed consent procedures, adverse event reporting, documentation, and record-keeping practices. Meticulousness with a focus on accuracy and precision in all tasks and activities. Extensive experience in clinical trial monitoring, including site initiation visits, routine monitoring visits, and close-out visits. Proficiency in monitoring plans, protocol adherence, and GCP guidelines. Conducting source data verification, resolving queries, and ensuring site compliance and data accuracy. Demonstrated ability to perform the essential duties of the position with or without accommodation. Authorization to work in the United States without sponsorship. Preferred Qualifications Experience or knowledge in In Vitro Diagnostics (IVD). Certifications related to clinical research. Working knowledge of the FDA submission process including IDE, PMA, and 510(k). Strong on-site monitoring experience in clinical trials, including: Site initiation. Routine monitoring visits. Site closeout. Knowledge of electronic trial master file (eTMF) systems and document management processes. This position requires the CRA to be based in either Chicago, IL or Dallas, TX and be fluent in Spanish. #LI-JH1 #LI-REMOTE We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed. All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not. Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office. ***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***

CRA II OR Senior CRA (home-based in the U.S.) ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Senior Clinical Research Associate or Clinical Research Associate II to join our diverse and dynamic team. As a Clinical Research Associate at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies. What you will be doing Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials. Ensuring protocol compliance, data integrity, and patient safety throughout the trial process. Collaborating with investigators and site staff to facilitate smooth study conduct. Performing data review and resolution of queries to maintain high-quality clinical data. Contributing to the preparation and review of study documentation, including protocols and clinical study reports Your profile Bachelor's degree in a scientific or healthcare-related field. Minimum of 1 year independent monitoring to be considered for a Clinical Research Associate II and a minimum of 3 years independent monitoring to be considered for a Senior Clinical Research Associate. In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines. Strong organizational and communication skills, with attention to detail. Ability to work independently and collaboratively in a fast-paced environment. Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver's license #LI-MM2 #LI-Remote What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family's needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future. Essential Functions and Other Job Information: Essential Functions Monitors investigator sites with a risk-based monitoring approach: applies root Functions cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable. Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System, CTMS). Performs QC check of reports generated from CTMS system where required. Participates in investigator meetings as necessary. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Ensures trial close out and retrieval of trial materials. Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications. Contributes to the project team by assisting in preparation of project publications/tools and sharing ideas/suggestions with team members. Performs additional study tasks as assigned by CTM (e.g. trip report review, newsletter creation, lead CRA team calls etc). Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts. Responds to company, client and applicable regulatory requirements/audits/inspections. Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner. Contributes to other project work and initiatives for process improvement, as required. Qualifications: Education and Experience: Bachelor's degree in a life science related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification. Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years as traveling clinical research associate). Valid driver's license where applicable. In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills and Abilities: Effective clinical monitoring skills Demonstrated understanding of medical/therapeutic area knowledge and medical terminology Excellent understanding and demonstrated application of ICH GCPs, applicable regulations and procedural documents Well-developed critical thinking skills, including but not limited to critical mindset, in-depth investigation for appropriate root cause analysis and problem solving Ability to manages Risk Based Monitoring concepts and processes Effective oral and written communication skills, with the ability to communicate effectively with medical personnel Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers' underlying issues Effective interpersonal skills Strong attention to detail Effective organizational and time management skills Ability to remain flexible and adaptable in a wide range of scenarios Ability to work in a team or independently as required Good computer skills: proficient knowledge of Microsoft Office and the ability to learn appropriate software Good English language and grammar skills Good presentation skills Compensation and Benefits The salary range estimated for this position based in Illinois is $79,200.00-$136,000.00. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes: A choice of national medical and dental plans, and a national vision plan, including health incentive programs Employee assistance and family support programs, including commuter benefits and tuition reimbursement At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount For more information on our benefits, please visit: *****************************************************

Ann & Robert H. Lurie Children's Hospital of Chicago provides superior pediatric care in a setting that offers the latest benefits and innovations in medical technology, research and family-friendly design. As the largest pediatric provider in the region with a 140-year legacy of excellence, kids and their families are at the center of all we do. Ann & Robert H. Lurie Children's Hospital of Chicago is ranked in all 10 specialties by the U.S. News & World Report. Location Ann & Robert H. Lurie Children's Hospital of Chicago Job Description Summary Based on specific research program needs, patient facing vs. data administrative responsibilities will vary. Coordinates all clinical research activities with moderate supervision. Coordinates & completes activities associated with the creation and implementation of participant recruitment strategies designed to enhance enrollment in a single complex, large, nationwide or multiple moderately complex concurrent biomedical &/or social-behavioral research studies involving multiple sites &/or longitudinal assessments/ interventions. Job Duties: Conducts study start-up activities and prepares and maintains all regulatory documents required by sponsor and/or regulatory agencies. Prepares protocols, informed consent documents, modifications, renewals and other necessary documents for review by the IRB and/or sponsor. Coordinates study conduct with other departments to effectively implement clinical research projects; obtains required letters of support and/or approvals as needed (i.e. IBC, SRC, etc.) and protocol is followed. Identifies and recruits eligible study subjects; conducts informed consent/assent process. Arranges and conducts clinical research visits. Conducts site qualifications, study initiation, monitoring and/or close-out visits. Attends investigator meetings. Abstracts data from medical records and enters medical information/data onto protocol specific case report forms, study flow sheets, and other required study forms; prepares abstracted/coded data for processing/analysis. Creates and/or updates case report forms and/or source document templates and/or data dashboards. Coordinates reimbursement of subjects. Maintains inventory of supplies/equipment. Prepares lab kits and requisitions prior to visits. Collects specimens from subjects and processes specimens or works with Research lab to ensure samples are processed/sent out correctly. Records data on source documents and CRF's and/or electronic web based systems. Conducts literature searches and assists with QA/QC procedures. Adheres to research protocol in compliance with applicable institutional, local and federal regulations (OHRP, FDA, GCP, etc.). Maintains all study documents (regulatory binders, source documents, correspondence, etc.). Promotes the ethical conduct of research by actively participating in research related educational meetings/conferences (planning, presenting, etc.). Performs job functions adhering to service principles with customer service focus of innovation, service excellence and teamwork to provide the highest quality care and service to our patients. QA/QC checks for database validity and data monitoring. Tracking deadlines for grants/deliverables. Recruitment Focused Tasks: Coordinates and guides the creation and implementation of a recruitment & retention plan associated with clinical research, Investigator Initiated, Sponsored, & Outcomes studies involving human subjects ensuring the protection of their safety, rights, and welfare. Determines, interprets and applies rules and regulations (LCH, local, state, federal, industry, sponsor, etc.) and recommends and guides principal investigators (PIs) and research staff in the creation, submission, documenting, reporting, etc. of study recruitment and enrollment activities ensuring appropriate compliance. Acts as liaison between research staff (PI, faculty, nurses, technicians, etc.), and internal/external regulatory and oversight groups (LCH's IRB, sponsors (NIH, industry), government agencies (FDA), etc.), advertisers, etc. to resolve issues and problems, negotiate compromises, and offer alternatives and recommendations to facilitate and expedite study recruitment and enrollment while ensuring compliance. Creates research study recruitment materials and execute implementation of marketing materials across multiple platforms (e.g., print, digital, radio, television). Designs recruitment screening tools and best practices to support clinical and outcomes research in collaboration with CRP's, DAR, IM, and the IRB. Facilitate script development and feedback sessions with hospital Advisory Boards and community stakeholders. Develop and facilitate research protocols related to measuring the use and effectiveness of educational videos and other recruitment materials in the research community. Investigator initiated, sponsored, and externally sponsored both type and sponsor (Focus on diversity & minorities) - evaluate barriers to increase recruitment of children, teenagers, and young adults who are underrepresented in bio-medical research Assist teams in creation of recruitment plans and materials prior to IRB submissions until study is completed. Move regulatory functions to bottom (not enforcement role) Other job functions as assigned. K.S.A.'s: High School Diploma with three to five years of clinical research experience -or Associates /two years of College with two to four years research experience -or- Bachelors with one to three years research experience. Knowledge of research regulations (FDA, OHRP, GCP, etc.) preferred. Good clinical practices documentation required. Familiarity and experience with FDA and IRB regulatory requirements preferred. Clinical Research Experience preferred. Education High School Diploma/GED (Required) Pay Range $83,200.00-$137,280.00 Salary At Lurie Children's, we are committed to competitive and fair compensation aligned with market rates and internal equity, reflecting individual contributions, experience, and expertise. The pay range for this job indicates minimum and maximum targets for the position. Ranges are regularly reviewed to stay aligned with market conditions. In addition to base salary, Lurie Children's offer a comprehensive rewards package that may include differentials for some hourly employees, leadership incentives for select roles, health and retirement benefits, and wellbeing programs. For more details on other compensation, consult your recruiter or click the following link to learn more about our benefits. Benefit Statement For full time and part time employees who work 20 or more hours per week we offer a generous benefits package that includes: Medical, dental and vision insurance Employer paid group term life and disability Employer contribution toward Health Savings Account Flexible Spending Accounts Paid Time Off (PTO), Paid Holidays and Paid Parental Leave 403(b) with a 5% employer match Various voluntary benefits: Supplemental Life, AD&D and Disability Critical Illness, Accident and Hospital Indemnity coverage Tuition assistance Student loan servicing and support Adoption benefits Backup Childcare and Eldercare Employee Assistance Program, and other specialized behavioral health services and resources for employees and family members Discount on services at Lurie Children's facilities Discount purchasing program There's a Place for You with Us At Lurie Children's, we embrace and celebrate building a team with a variety of backgrounds, skills, and viewpoints - recognizing that different life experiences strengthen our workplace and the care we provide to the Chicago community and beyond. We treat everyone fairly, appreciate differences, and make meaningful connections that foster belonging. This is a place where you can be your best, so we can give our best to the patients and families who trust us with their care. Lurie Children's and its affiliates are equal employment opportunity employers. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin, ancestry, age, disability, marital status, pregnancy, protected veteran status, order of protection status, protected genetic information, or any other characteristic protected by law. Support email: ***********************************

Senior CRA Responsibilities include: * All aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, writing of clinical trial reports, conduct of pre-study and initiation visits, liaise with vendors and other duties * All aspects of site and registry management as prescribed in the project plans * Organize and make presentations at Investigator Meetings * Report, write narratives and follow-up on serious adverse events * Review progress of projects and initiate appropriate actions to achieve target objectives * You may serve as lead monitor for a protocol or project and assist in establishing monitoring plans if required * Participate in the development of protocols and Case Report Forms as assigned * Interact with internal work groups to evaluate needs, resources and timelines Qualifications * 5+ years of clinical research monitoring experience (including pre-study, initiation, routine monitoring and close-out visits) preferably in a CRO or Pharma environment * Ability to monitor study sites independently according to protocol monitoring guidelines, S.O.P.s, GCP and ICH Guidelines * Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of Seas * Good knowledge of ICH Guidelines and GCP, monitoring procedures and understanding of the clinical trial process * Good planning, organization and problem solving abilities * Good communication and interpersonal skills Additional Information All your information will be kept confidential according to EEO guidelines.

Senior Clinical Research Associate (home based) (level dependent on experience) Job Purpose/Summary To help support the unique job functions of our CRAs, we have a dedicated training department that offers ongoing therapeutic training sessions from our world-class medical directors, and an experienced and supportive management team that is there to offer continual guidance. Additionally, all CRAs are able keep their hotel points and airline miles and are offered a home office allowance. Maintaining our company culture across all regions, and especially with our remote employees, is incredibly important to our overall success. To do so, we have weekly all-staff meetings in which each department can provide an update on a study or milestone that they have achieved. Each employee also has the opportunity join one of our CTI Cares committees that not only help support our culture, but also focus on our various philanthropic efforts. What You'll Do Manages investigative site activity for multiple protocols / indications and provides ongoing updates of site status to Project Manager / sponsor Creates and implements subject enrollment strategies for assigned investigative sites. Conducts study site visits (pre-study, initiation, monitoring, and close-out) and completes site visit deliverables within given timelines in the Monitoring Plan. Ensures proper storage, dispensation, and accountability of all investigational product(s) and trial-related material. Maintains tracking records for assigned sites including tracking of subject status, subject case report form (CRF) retrieval / source document review (SCV), regulatory documents, and investigational product. Participates in development of CRFs and other study related documents What You Bring Bachelor's or Master's Degree in allied health fields, such as nursing, pharmacy, or health / natural science, or RN with Associate's Degree or 3-year Nursing Diploma with at least 2 years of clinical nursing experience Why CTI? At CTI, we recognize that our people are what make our company successful. Our work moves medicine forward. For that reason, we treat our team members with the respect they deserve, and our numbers show it: We support career progression - We believe in promoting from within and we have a structured mentoring program and program for recent graduates to provide the support employees need to move forward We value education and training - We provide tuition assistance, partner with universities and colleges to create programs in our field, and have a dedicated training department We value our people - We have never had a layoff in our three decade history and we guaranteed full pay for our employees during the COVID-19 shut-down regardless of the number of hours worked. We support a work-life balance and the importance of time with family by offering generous vacation time, a hybrid work from home schedule, and paid parental leave. Our culture is unparalleled - We've received multiple awards recognizing CTI as one of the best places to work in the greater Cincinnati area, as well as one of the top CROs in the industry We think globally and act locally - With employees across 60 countries, we have global reach but maintain culture and connections to the local communities in which we work. Our CTI Cares Committees are dedicated to ensuring the CTI culture and values translate around the world. We are looking toward the future - We have had a consistent double-digit growth rate over the last decade, invest in cutting-edge technology, and pride ourselves on our average annual retention rate of 95%, which is much higher than many other CROs Our work makes a difference - We focus our work on treatments for chronically and critically-ill patients, who are depending on us to bring these life-changing therapies to market

Job DescriptionAbout Hematogenix Want a job with greater meaning and higher purpose? Every day Hematogenix employees are warriors fighting a noble and global war on cancer. Helping patients every day, and helping partners every day - with our diagnostic and research services. Hematogenix is looking for talented and highly motivated individuals to join our team. We offer a competitive benefit package and career development opportunities to help you achieve your highest professional and personal goals. We are eager to show you all we have to offer and how you can grow with us. Hematogenix is a specialized contract research organization and clinical laboratory with a global presence. Our team of board-certified clinical, anatomic and research pathologists work in conjunction with top scientists from around the world to provide quality testing, consultation, and guidance for all aspects of the company's pharma and diagnostic services. Job Purpose: The Clinical Study Coordinator supports the successful delivery of clinical trial projects via operational/day-to-day management of workflows. Deliver excellent customer service to project stakeholders (e.g., clients, clinical sites). *Please note that this position requires you to be onsite at our Illinois, USA location. Accountabilities/Work Activities: Study Initiation Possess strong working knowledge of company capability's and how it typically aligns with clients' objectives and timelines. Comfortable developing and maintaining relationships with various project stakeholders where needed (external and internal) Planning & Design Contribute, when necessary, operational insights that will impact project scope. Assist the Project Managers with creation of study specific laboratory binders and regulatory documents. Executing Attend in-house initiation meetings with all project personnel in order to understand individual contributions of all, as well as overall study objectives and timelines. Provide guidance to Pharma Accessioning Team regarding query generation. Create and send clearly written data clarification messages to ensure outstanding queries are resolved in a timely fashion according to Communication and Escalation Plan established with each Sponsor. Maintain study tracking spreadsheets/documents in real time if applicable. Communicate effectively (verbal and written) when interacting with external stakeholders (e.g., CRAs, SCs, PIs, etc.) Interact effectively with all in-house project personnel and provide clear communication on status of cases (query resolution) or specific requests (e.g., expedited testing requests Perform data entry if needed and/or manage data entry needs of projects to ensure daily/weekly completion occurs. Process sample repatriations and maintain associated documentation. Monitoring & Controlling Participate in regular internal meetings with Project Manager to feed in views of project personnel, outline operational challenges, and learn of wider project progress. Participate in regular conference calls with clients. Provide support to Project Manager during client monitoring visits. Ensure project supplies and day-to-day resources are always appropriately used in an effort to reduce waste and increase efficiency. Study Closing Contribute to internal project closing meetings in order to share best practice. Provide QC support to Project Manager during close out visits. Experience and Education Bachelor of Science degree or similar degree related to the role 1-2 years' experience in Clinical Laboratory Science Skills and Qualifications Knowledge of GCP/CAP/CLIA and global clinical research industry Must be able to communicate effectively and persuasively, both verbally and in writing, with all levels of in-house Hematogenix personnel and other project stakeholders (e.g., CRAs, site officials) Working experience with laboratory information systems Personal computer skills (Microsoft Word, Excel, Power Point, etc.) Ability to ambulate throughout the office and laboratory. Benefits we Offer: Medical Dental Vison Life 401k PTO Competitive Salary Contact Information: ********************; ******************* Hematogenix provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

Details Job Title CLINICAL RESEARCH COORDINATOR II Position Number 8150821 Work Modality Job Category University Staff Job Type Full-Time FLSA Status Non-Exempt Campus Maywood-Health Sciences Campus Department Name ORTHOPAEDIC SURGERY Location Code CLINICAL RESEARCH OFFICE (06124A) Is this split and/or fully grant funded? Yes Duties and Responsibilities Position Summary The Research Assistant supports the Department of Orthopaedic Surgery in the design, implementation, and administration of clinical research projects. This position works collaboratively with Principal Investigators (PIs), biostatisticians, residents, medical students, and other research staff to ensure regulatory compliance, data integrity, and the timely and efficient execution of departmental research and grant activities. Essential Duties and Responsibilities Regulatory and Compliance * Prepare and submit new IRB applications in accordance with institutional policies and procedures. * Submit and track amendments, continuing reviews, and study closures for active protocols. * Draft, review, and maintain informed consent documents to ensure accuracy and regulatory compliance. * Track and ensure completion of CITI and other required research trainings. * Recognize and uphold ethical and compliance standards within assigned research activities. Research Administration * Maintain departmental research administrative files, regulatory binders, and project documentation. * Manage and update a comprehensive list of faculty and resident research publications. * Prepare and submit research database requests and data use agreements (DUAs) for multi-institutional studies. * Organize, review, and assist with grant submissions and grant budget preparation. * Participate in project feasibility reviews and study initiation visits. * Provide strategic guidance on study setup and implementation to ensure successful study launches. * Assist with research-related reimbursements, supply procurement, and other administrative processes. * Coordinate monthly research meetings for clinical subdivisions within the department. Data Management and Analysis * Design and format research databases and surveys using REDCap and Excel platforms. * Perform data entry, organization, quality assurance, and data cleaning to ensure completeness and accuracy. * Collaborate with biostatisticians on study design, data analysis, and interpretation of findings. Study Coordination * Conduct literature reviews and synthesize findings to support ongoing and new research projects. * Screen potential participants, recruit subjects, and obtain informed consent under PI direction. * Maintain secure shared files for on-site and remote project management. * Coordinate study-specific meetings and maintain effective communication across study teams. Manuscript and Presentation Support * Assist in the preparation of research findings, figures, and tables for reports, abstracts, and presentations. * Format, edit, and submit scientific manuscripts to peer-reviewed journals and conference proceedings. Education and Training * Train new research assistants and medical students in research processes and best practices. * Organize logistics for the annual research course for incoming interns and summer medical students. Other Responsibilities * Incorporate new processes, techniques, and technologies into research operations with Clinical Research Director or Chair approval. * Perform additional duties as assigned by Principal Investigators. * Maintain a positive, organized, and safe work environment. * Performs other duties as assigned. Minimum Education and/or Work Experience * Bachelors Degree OR equivalent training acquired via work experience or education * 2-5 years of previous job-related experience Qualifications Education and Experience Requirements * Minimum: Bachelor's degree in a scientific or health-related field. * Preferred: Master of Public Health (MPH) or equivalent advanced degree. * Experience: Minimum of 3-5 years of post-education research experience, preferably in an academic, clinical, or healthcare setting. Preferred Qualifications * Hands-on experience conducting clinical research in an academic or healthcare environment. * Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook). * Strong organizational, communication, and interpersonal skills, with the ability to collaborate effectively in multidisciplinary teams. * Demonstrated ability to manage multiple projects and meet deadlines with accuracy and attention to detail. * Experience with database design, data management, and research software (REDCap preferred). * Familiarity with grant development, including proposal preparation and budget drafting. * Experience with manuscript preparation and scientific writing. Certificates/Credentials/Licenses N/A Computer Skills Basic computer skills Supervisory Responsibilities No Required operation of university owned vehicles No Does this position require direct animal or patient contact? No Physical Demands None Working Conditions None Open Date 12/01/2025 Close Date Position Maximum Salary or Hourly Rate $28.92/hr Position Minimum Salary or Hourly Rate $21/hr Special Instructions to Applicants As a Jesuit, Catholic institution of higher education, we seek candidates who will contribute to our strategic plan to deliver a Transformative Education in the Jesuit tradition. To learn more about Loyola University Chicago's mission, candidates should consult our website at ********************* For information about the university's focus on transformative education, they should consult our website at ***************************** About Loyola University Chicago Founded in 1870, Loyola University Chicago is one of the nation's largest Jesuit, Catholic universities, recognized for its academic excellence, commitment to community engagement, and leadership in sustainability. A Carnegie R1 research institution, Loyola leverages its status as one of an elite group of universities with the highest level of research activity to advance knowledge that serves communities and creates global impact. With 15 schools, colleges, and institutes-including Business, Law, Medicine, Nursing, and Health Sciences-Loyola operates three primary campuses in the greater Chicago area and one in Rome, Italy, that provide students a transformative, globally connected learning experience. Consistently ranked among the nation's top universities by U.S. News & World Report, Loyola is a STARS Gold-rated institution that is ranked as one of the country's most sustainable campuses by The Princeton Review and has earned distinctions from AmeriCorps and the Carnegie Foundation for its longstanding record of service and community engagement. Guided by its Jesuit mission and commitment to caring for the whole person, Loyola educates ethical leaders who think critically, act with purpose, and strive to create a more just and sustainable world. Loyola University Chicago strives to be an employer of choice by offering its staff and faculty a wide array of affordable, comprehensive, and competitive benefits. To view our benefits in detail, click here. Loyola adheres to all applicable federal, state, and/or local civil rights laws and regulations prohibiting discrimination in private institutions of higher education. Please see the University's Nondiscrimination Policy.

Business Unit: Rush Medical Center Hospital: Rush University Medical Center Department: Preventive Medicine-Res Adm **Work Type:** Full Time (Total FTE between 0.9 and 1.0) **Shift:** Shift 1 **Work Schedule:** 8 Hr (8:30:00 AM - 5:00:00 PM) Rush offers exceptional rewards and benefits learn more at our Rush benefits page (***************************************************** **Pay Range:** $21.61 - $30.53 per hour Rush salaries are determined by many factors including, but not limited to, education, job-related experience and skills, as well as internal equity and industry specific market data. The pay range for each role reflects Rush's anticipated wage or salary reasonably expected to be offered for the position. Offers may vary depending on the circumstances of each case. Temporary - This position may be limited to 1-2 years **Summary:** The EPI Research Coordinator 1 coordinates Epidemiological, Behavioral or Human Translational, or Population Health research studies and performs a variety of duties including the collection compilation and documentation of research data. The Coordinator 1 partners with other members of the research team to ensure the research is conducted in accordance with the study protocol, local, state, and federal guidelines related to epidemiologic/ behavioral/ translational research. Exemplifies the Rush mission, vision and values and acts in accordance with Rush policies and procedures. **Required Job Qualifications:** - Bachelor's Degree in related field. - Two years general research experience with two years working on Human Subjects research. - Demonstrate knowledge of Good Epidemiological Practice (GEP) and/or Good Clinical Practice (GCP). - Strong organizational skills. - Demonstrates basic computer skills. - Strong written and verbal communication skills. - Ability to collaborate within multi-disciplinary team settings. - May require personal transportation to field location depending on assignment. - Ability to work independently. - Ability to develop and maintain effective relationships with a variety of stakeholders. - Availability to work evenings, overnight and weekends if called for under the study protocols. **Responsibilities:** - Coordinates aspects of less complex research studies including, but not limited to, study start-up, initiation activities, participant recruitment, enrollment, completion of data collection, maintenance of data integrity, and study close-out. - Assists with the development of study related Standard Operating Procedures for new study protocols. - May assist in the collection of study data both through interviews and collecting samples or testing results as described by the study protocol. - May assist with preliminary data organization and/or guided analysis. - Primary participant contact for all study related questions and issues. - May help coordinate study team workload and training schedules to ensure optimal use of resources. - Follows Federal and Rush guidelines in the collection of study data and other study related activities. - Troubleshoots field issues when necessary. Uses discretion to resolve issues when unplanned events arise. - May assist with Institutional Review Board (IRB) assignments such as initial study approval, amendments, continuing reviews and updating study documents for IRB approval. - May assist PI with aspects of grant proposals. - May act as lead for less experienced Research Assistants, work-study students, interns and volunteers including orientation, training, and providing performance feedback. Rush is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics. **Position** Epi Research Coordinator 1 - Temporary, Full Time **Location** US:IL:Chicago **Req ID** 22734

The Clinical Research Coordinator will perform and manage tasks that are critical to clinical research studies. The Clinical Research Coordinator must ensure compliance with federal regulations, study protocol guidelines, as well as monitor study participants, and take a proactive approach to identify issues on an ongoing basis throughout the clinical research study. To consistently embody AMR Clinical's Core Values: United We Achieve Celebrate Diverse Perspectives Do the Right Thing Adapt and Persevere The Clinical Research Coordinator reports to the Site Manager/Team Lead. Classification: Non-Exempt Primary Responsibilities: Focuses on compliance responsibilities, including protocol deviations, SAE reporting, and informed consent. Strong focus on compliance responsibilities, including managing protocol deviations, SAE reporting, and ensuring proper informed consent procedures. Coordinate clinical trials per FDA requirements and GCP Guidelines per sponsor protocols. Manage and document Adverse Event and Serious Adverse Event reporting in compliance with FDA, IRB, and sponsor requirements, ensuring timely follow-up and resolution. Establish understanding of SOP's and implement the SOP's Gain understanding of the pharmaceutical drug per clinical trial. Develop detailed knowledge of protocol and procedures per clinical research study. Communicate effectively with study sponsors, CROs, monitors/CRA's, IRBs, laboratories, and clinical personnel within the research industry. Be the study ambassador on assigned studies to advise team members on protocols and procedures to ensure successful implementation and completion of the clinical research study. Establish and maintain patient rapport. Clinical data collection (vital signs, EKG recording, weight, height, etc.) Obtain medical records and review as required. Phlebotomy Specimen collection, processing, and storage Transporting clinical specimens to the laboratory. Educate subjects on diaries and oversees compliance with diary completion. Provides subjects instructions per study (diaries, restricted meds, study reminders, etc.) Responsible for completing patient phone call visits in accordance to the standard protocol period. Ensure documentation follows ALCOA standards and is completed in a timely manner. Ensure all necessary documents are completed, signed and dated. Provides required information to Contract Research Organization (CRO), Institutional Review Board (IRB), sponsoring organization, Food and Drug Administration (FDA), and/or other appropriate agency as required. Manage study inventory and order supplies as needed. Prepare and assist study monitors during onsite visits. Maintain familiarity with all ongoing clinical research studies. Travel to Investigator meetings as needed. Promote team mentality by working flexible hours as needed and completing tasks outside the scope of everyday duties Position may require occasional weekend and/or overtime hours. Other duties as assigned Desired Skills and Qualifications: 1 year of experience in clinical research. Completion of formal medical training, educational program, or healthcare experience Strong medical terminology Ability to perform clinical, laboratory, and diagnostic tests (vital signs, height, weight, temperature, etc.). Ability to work independently and lead study-related tasks. Ability to multi-task in a high-paced evolving environment. Exceptional listening, written, and verbal communication skills as well. Demonstrate proficiency in office equipment and software programs. Excellent organizational and task management skills. Ability to be ambulatory most of the workday. Ability to lift/transfer/push/manipulate equipment and patients, which requires strength, gross motor and fine motor coordination. AMR Clinical does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, retaliation, parental status, military service, or other non-merit factor. ** This job description is intended to be a representative summary of the major responsibilities and accountabilities of the staff holding this position. The staff may be requested to perform job-related tasks other than those stated in this description.

Clinical Research Coordinator I The Clinical Research Coordinator I, will ensure that quality research is conducted at the assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines and to provide the best quality data to the sponsor. The CRC I will also ensure study enrollment meets or exceeds Sponsors' expectations. To ensure company goals are achieved on a timely basis. Duties & Responsibilities: Completing all the DMCR-required training, including but not limited to ICH-GCP Certification and IATA Certification on a timely basis. Completing all the relevant training prior to study-start and on a continued basis in a timely manner. This will include but is not limited to: a. Sponsor-provided and IRB-approved Protocol Training b. All relevant Protocol Amendments Training c. Any study-specific Manuals Training, as applicable d. Sponsor-specified EDC and/or IVRS and any other relevant Electronic Systems training. Conducting study subject visits, and all other relevant protocol-required procedures and documenting these in a timely manner. Adherence to ALCOA-C Standards with all the relevant clinical trial documentation. Completing data entry and query resolution in a timely manner as per internal company guidelines and as per sponsor expectations. Demonstration of appropriate and timely follow-up on the action items, at their respective sites. Demonstrated understanding and implementation of Laboratory Manuals and protocol-specified laboratory procedures, storage, temperature monitoring, equipment calibration and laboratory kit inventory, under the direction of the Site/Study Management Team, for assigned protocols. Liaising with Laboratory team, Data team, Administrative staff, Clinical Investigators, Research Participants and Sponsor/CRO representatives, under the direction of the Site/Study Management Team, for assigned protocols. Submitting required administrative paperwork per company timelines. Participating in subject recruitment and retention efforts. Engaging with Research Participants and understanding their concerns. Any other matters, as assigned by management. Knowledge & Experience: Education: High School Diploma or equivalent required Bachelor's degree a plus Foreign Medical Graduates preferred Experience: At least one years of experience as a CRC, preferably with practice coordinating industry-sponsored vaccines in a private setting. At least two years of experience as a research assistant, data coordinator, laboratory personnel, or equivalent experience in a clinical research setting Credentials: ACRP or equivalent certification is preferred Registered Medical Assistant certification or equivalent is preferred Knowledge and Skills: Be an energetic, go-getter who is detail-oriented and can multi-task. Be goals-driven while continuously maintaining quality. Bilingual in Spanish is preferred

Job Title: Clinical Research Coordinator III - Team Lead Department: Clinical Research Operations Schedule: Full-time, Monday through Friday (8AM-5PM) -additional flexibility required to meet job requirements Reports To: Director of Clinical Trials Position Summary The Clinical Research Coordinator III - Team Lead is a senior-level hybrid role responsible for leading the coordination of complex clinical trials while supervising and mentoring the on-site research team. This position functions as a "player/coach," combining direct study coordination with oversight of Clinical Research Coordinators and Clinical Research Assistants. The CRC III - Team Lead ensures operational excellence, regulatory compliance, and a culture of accountability and continuous improvement. This role also collaborates closely with the Patient Recruitment department to support enrollment success through candidate prescreening, outreach, and community engagement. In addition, the CRC III - Team Lead supports regulatory and quality functions directly with the team and in collaboration with centralized regulatory and quality resources. Core Competencies * Advanced knowledge of clinical trial operations, GCP, FDA regulations, and IRB processes * Strong leadership and coaching skills with a collaborative, solutions-oriented mindset * Excellent communication and interpersonal abilities across diverse stakeholders * High attention to detail, time management, and multitasking capabilities * Commitment to quality, compliance, and participant safety Key Responsibilities Study Leadership and Coordination * Serve as lead coordinator on high-priority or complex trials, managing all phases from startup to closeout * Provide backup coverage and operational support for other coordinators during absences or escalations * Ensure protocol adherence, timely data entry, and accurate documentation across assigned studies Team Supervision and Mentorship * Supervise and mentor Clinical Research Coordinators I and II and Clinical Research Assistants * Lead onboarding, training, and ongoing development for study staff * Conduct regular team huddles, protocol reviews, and best practice sessions Regulatory and Quality Support * Support regulatory and quality functions directly with the team and in collaboration with centralized regulatory and quality resources * Ensure accurate completion, review, and submission of IRB documents, amendments, and safety reports * Maintain essential regulatory files and sponsor communications * Participate in internal audits, monitoring visits, and CAPA implementation Patient Recruitment and Engagement * Partner with the Patient Recruitment department to develop and execute enrollment strategies * Conduct candidate prescreening and outreach activities to support recruitment goals * Participate in community engagement efforts to raise awareness and build trust with potential participants Operational Collaboration * Serve as liaison between the research team, investigators, sponsors, and institutional departments * Assist in resource planning, visit scheduling, and workload balancing * Contribute to SOP development, workflow optimization, and quality improvement initiatives Qualifications and Requirements * Education: Bachelor's degree in life sciences, nursing, or a related field * preferred * Experience: Minimum 4 to 6 years of clinical research coordination experience, including leadership or mentorship responsibilities * Certification: Clinical research certification (e.g., ACRP, SOCRA) preferred * Technical Skills: Proficiency in CTMS, E-Source, E-Reg, EDC platforms, and regulatory systems; strong computer literacy (Microsoft Office Suite, electronic communication tools) * Knowledge Base: Advanced understanding of clinical trial operations, GCP, FDA regulations, and IRB processes * Communication: Excellent written and verbal communication skills; ability to interact effectively with investigators, sponsors, staff, and participants * Leadership: Demonstrated ability to supervise, mentor, and develop staff while fostering accountability and collaboration * Organizational Skills: High attention to detail, time management, and multitasking capabilities; ability to prioritize competing demands * Flexibility: Willingness to adjust schedule to accommodate study visits, meetings, and events that may occur earlier, later, or on weekends * Travel: Ability to travel to training meetings, conferences, satellite sites and other Insight Health System locations as required * Professional Standards: Commitment to quality, compliance, participant safety, and continuous improvement

Unique opportunity to make an Impact in the healthcare industry Revival Research Institute, LLC was established in 2015, and headquartered in the Metro Detroit Region, and has been growing ever since. Revival now has a national presence in the Metro-Detroit Region, Texas, Illinois, and Arizona. We have been nationally acknowledged for our diligence to provide the highest quality of data for our clinical research trials. As Revival Research Institute is growing, we are looking to add more qualified professionals to our team, who are looking for an opportunity to grow and learn with us. We are seeking a full-time Clinical Research Coordinator with a minimum of 1 year of clinical experience, for our Additionally, someone with a strong interest in the Clinical Research field would be an excellent fit for our entry level position, with room to grow. However, this interest and background is not necessary, as our ideal candidate is an individual who is detail orientated, being able to maintain organized records, as well as someone who is motivated to learn new things, as our company is always growing and expanding into new therapeutic areas. We are looking for individuals that want the opportunity to learn and grow with us. Clinical Research Coordinators here at Revival Research Institute, should be genuinely respectful of diverse points-of-view and strive for an environment in which inclusiveness drives productivity and results. Clinical Research Coordinators are responsible to coordinate and manage multiple studies. They are also responsible for assisting the Investigators along with other clinical staff, with any study related tasks as follows but not limited to: Participates in research participant screening, recruitment and enrollment. Consent and conduct research visits for data collection/no risk trials or no study article/minimal risk trials with oversight. Responsible for collecting, processing and shipping of research specimens, where applicable. Documents study related information in case report forms or electronic data capture systems, handles data queries and participates in monitoring visits. Obtain, review and maintain source documents. Maintains organization of all trial related documents and correspondence. Implement quality control and assurance methods. Communicate with study sponsors, research team and the Institutional Review Board. Assist with basic regulatory document preparation, with oversight e.g. study amendments, adverse event reporting, protocol deviation reporting. Maintain professional and technical knowledge about Clinical trials. Research participant/family communication, protect patient confidentiality. Preferred Qualifications: Education/ Training: Bachelor's degree in health-related field with one to two years relevant clinical experience OR Master's degree in medical related field with no research experience. Individuals with more experience are preferred, if qualifications exceed entry level, higher positions available. Phlebotomy skills preferred. Psychology experienced with knowledge regarding the psychiatric rating scale is preferred. Certifications, Licensures, and Registrations: National Certification (CRA or ACRP), BLS Certification. Additional Qualifications: Expert database and computer skills: Microsoft Office (Word, Excel), Outlook, excellent verbal and written communication skills, ability to work independently and assume responsibility, excellent organizational skills, ability to meet data deadlines and maintain confidentiality. Maintain data integrity within the department. Must be able to work in a team consisting of physicians, nurses, technicians, secretarial staff and ancillary hospital staff. Knowledge of FDA Regulations and Good Clinical Practices. IMPROVE THE FUTURE AS OUR CLINICAL RESEARCH COORDINATOR!!!

We are seeking a highly organized and motivated Clinical Research Coordinator (CRC) to join our research team. The CRC will coordinate and support all aspects of clinical trials and research studies, including subject recruitment, data collection, regulatory compliance, and specimen handling. Candidates with current Phlebotomy certification or Medical Assistant (MA) certification are strongly preferred, as this role may include specimen collection and basic clinical procedures. Key Responsibilities: Coordinate day-to-day clinical research activities to ensure study protocols are followed. Recruit, screen, and enroll study participants. Obtain informed consent and ensure ethical conduct in all study interactions. Collect, process, and ship biological specimens per protocol (e.g., blood draws, urine samples). Perform basic clinical procedures as permitted by certification (e.g., vital signs, EKGs). Maintain accurate and timely documentation in case report forms and electronic databases. Communicate with sponsors, monitors, and IRBs regarding study progress and compliance. Schedule participant visits and follow-ups; ensure visit windows are met. Ensure proper storage, handling, and accountability of investigational products, if applicable. Maintain regulatory documents and assist with IRB submissions. Qualifications: Bachelor's degree in a health-related field required. At least 1 2 years of experience in clinical research preferred. Phlebotomy certification or MA certification preferred. Knowledge of Good Clinical Practice (GCP) and regulatory guidelines. Excellent organizational skills and attention to detail. Strong interpersonal and communication skills. Proficiency in Microsoft Office and electronic data capture systems (e.g., REDCap, EDC platforms). Ability to work independently and as part of a multidisciplinary team. Preferred Qualifications: Experience working in clinical trials, especially in a hospital or academic setting. Familiarity with IRB processes and clinical trial documentation. Bilingual skills (depending on patient population) may be a plus. Job Type: Full-time Work Location: In person Schedule: 8 hour shift Monday to Friday Weekends as needed

University Retina is a full-service practice that specializes in helping patients heal eyesight-robbing diseases of the retina, vitreous, and macula. Led by a team of board-certified ophthalmologists and retina specialists, the practice has locations in Oak Forest, Bedford Park, Lemont, Lombard, and Lincolnwood, Illinois. With a dedication to education, technology, charity, and compassionate care, the University Retina team strives to provide patients with the highest level of retinal care in the world. The physicians diagnose and treat retinal-related conditions, including macular degeneration, diabetic retinopathy, retinal detachment repair, and other disorders of the retina, vitreous, and macula. All University Retina offices are equipped with state-of-the-art technology, and each patient's treatment plan includes the most current and effective therapies or services available. Position Summary We are now hiring for a Clinical Research Assistant that will support a high-volume Resarch Department within an ophthalmic practice that focuses on providing quality and compassionate care to each patient needed complete eye care services. Pay Range - $21.00-$23.50/hr. Commensurate with experience Responsibilities A CRA is responsible for performing procedures and coordinating the execution of clinical trials in accordance with research protocols. • Recruit and screen subjects to participate in trials • Coordinate patient visits and perform procedures related to research • Collect accurate data obtained from research visits • Monitor research participants to ensure adherence to study protocol • Adhere to Good Clinical Practice (GCP) guidelines including regulatory and ethical standards • Maintain relationships with site staff, study subjects, and sponsor delegates • Perform other related duties as assigned by the Clinical Research Coordinator • Maintain compliance with all research Standard Operating Procedures (SOPs) Qualifications • 2+ years in healthcare, preferably ophthalmology, but not necessarily in clinical research • Analytical mindset • Attention to detail • Exceptional interpersonal skills • Superior verbal and written communication skills • Understanding of laboratory procedures and equipment • Proficiency in MS Office - Word, Excel and Outlook • High school diploma or equivalent GED Company Benefits We offer a competitive benefits package to our employees: Medical Dental Vision 401k w/ Match HSA/FSA Telemedicine Generous PTO Package We also offer the following benefits for FREE: Employee Discounts and Perks Employee Assistance Program Group Life/AD&D Short Term Disability Insurance Long Term Disability Insurance For more information related to our benefits offered, please follow the link to our benefits page: *********************************************************** (If the link does not work for you, please copy and paste it into your browser). EyeSouth Partners is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.